TW201410256A - Examining material of ingestion swallowing function - Google Patents

Abstract

The present invention provides an examining material of ingestion swallowing function, having a form capable of detailedly and accurately examining the movement or function and the degree of disability of ingestion swallowing. The present invention provides an examining material of ingestion swallowing function which presents one of the forms of liquid, viscous liquid, jelly-like semi-solid and even sticky solid, or an examining material of ingestion swallowing function which is formed by combining two or more kinds of the examining materials. It is possible to detailedly and accurately examine the movement or function and the degree of disability of ingestion swallowing for those whose ingestion swallowing function is reduced or the like by using one on more examining material or a combined examining material.

Description

Inspecting material for ingesting swallowing function

The present invention relates to a test material for ingesting swallowing function which can check the movement or function of the digestive tract such as the oral cavity, the pharyngeal head, and the like when ingesting food. In more detail, the purpose is to examine the clinical feeding/swallowing disorder, the method of treatment/disposal in conjunction with the degree of feeding/swallowing, and to suggest a proper and safe diet for those who have reduced swallowing function. Checking material for swallowing function.

In Japan, in order to respond to the super-aged society, we are striving to provide a more effective and efficient medical/care service through the strengthening of the collaboration between medical institutions and medical care and care.

On the other hand, due to diseases such as cerebrovascular disorders or an increase in age, the number of patients with food intake/dysphagia who have reduced swallowing function is increasing. In addition to being a major cause of aspiration pneumonia or dehydration/nutrition, feeding/swallowing disorders can also lead to a decrease in quality of life (QOL) due to loss of eating pleasure.

Therefore, in the joint operation of medical care and nursing care, in order to improve the QOL of these patients and reduce the medical expenses, it is necessary to commonize the inspection method or evaluation method of the feeding/swallowing function between the medical and nursing sites.

In the past, the diagnosis of the ingestion/swallowing function of the subject was performed to confirm the presence or absence of swallowing disorder, the degree of disorder, or the eating form. For the diagnosis of swallowing function, for example, the subject is allowed to take a liquid in which insoluble barium sulfate is dispersed in water, a viscous liquid to which a tackifier is added, or is prepared by a tackifier or a gelling agent and processed into a jelly form. (In the case of the gel-like test article (hereinafter, the case where only "gel" is used), the method of observing the dispersion or the gel through the pharyngeal and esophagus (Patent Document 1). These are called Videofluorography (VF) and are popularized as a powerful method for examining swallowing function.

In addition, an endoscope is provided through the upper pharyngeal head to observe the state of passage of food in the pharynx by video endoscopy (VE) or Computed Tomography (CT), nuclear magnetic resonance imaging ( Magnetic resonance imaging (MRI), Ultrasonography (US Echo), etc., for the examination of the movement or function of feeding/swallowing.

In these inspection methods, a simulated food that is in the form of a meal or a food is used as an examination object, and the patient is ingested/swallowed, and the dynamics or the presence or absence of obstacles or aspirations are observed from the television image for diagnosis. . At this time, in order to present a contrast in the image, a contrast agent is added to the inspection food. For example, in X-ray photography, a substance that sufficiently shields X-rays is added to the test object.

Further, in the examination of the swallowing function, the dynamics of swallowing changes depending on the physical properties such as viscosity, hardness, and adhesion of the dispersion or the jelly used in the examination. Therefore, it is necessary to develop a contrast-simulated food in which the physical property indexes are adjusted stepwise (Patent Document 2).

Further, it is known that a viscous liquid or a jelly prepared by adding such a contrast agent changes its physical properties such as viscosity, hardness, or adhesion over time. For example, when barium sulfate is used as a contrast agent for VF examination, such reports are available. Therefore, try to develop time-varying A tackifier for contrast agents which is less stable and exhibits stable physical properties (Patent Document 3).

Patent Document 1: Japanese Patent Laid-Open No. 11-292796

Patent Document 2: Japanese Special Open 2006-109723

Patent Document 3: Japanese Special Opening 2001-48810

As described above, the swallowing inspection is performed via various inspection objects. However, in each institution, a wide variety of such examinations are used, and even if the swallowing function and the eating pattern are determined based on the prepared examination object, the judgment or diagnosis of each institution is performed according to the experience of each physician. Therefore, it has not been unified.

Further, the physical properties of the test object, that is, the viscosity, the hardness, the adhesion, the agglutinability, and the like are often different depending on the modulator or the preparation method, and this problem is not only caused between the respective mechanisms but also within the mechanism. In addition, in addition to the need to modulate the fees, the inspections are also varied.

Because of this situation, regarding the diagnosis based on the ingestion swallowing examination, the determination of the eating pattern, etc., due to the failure to share appropriate information between the institutions, the patients with the transfer treatment institution need to be re-examined before and after entering the hospital. Or if you want to transfer to a diet that provides an inappropriate form.

Further, in terms of the form of the swallowed test article, it is reported that there are liquid, thick liquid, thick mud-like food/paste food, thick cut food, and jelly. For example, in the above-mentioned Patent Document 1, a swallowing test product which is processed into a jelly form (gel form) by a tackifier or a gelling agent is exemplified, and similarly, in Patent Document 2, a sol having fluidity is exemplified ( Swallow test of sol-like liquid.

However, in the case of these single forms of jelly or liquid, the physical properties such as hardness, adhesion, and viscosity are changed only in the original form to modulate a plurality of test objects, and since the physical properties are different, only the disease can be evaluated. Suffering from eating disorders. Moreover, since the jelly-like and liquid forms do not necessarily need to be chewed, the inspection of this form can only check the dynamics/function of liquid swallowing of the so-called "whole swallowing".

In the motor function of normal human feeding and swallowing, the basic steps can be roughly divided into: "liquid swallowing" for swallowing without chewing liquid or jelly, and "chewing and swallowing" with chewing of solid matter, according to Take different steps to eat and swallow.

Here, the "liquid swallowing" step is constituted by four periods of the following 1) to 4) called "four-stage model".

1) Oral preparation period

After taking food (liquid or gel) into the mouth, place it in the center of the back of the tongue until it is ready to be swallowed.

2) Delivery to the oral cavity

In accordance with the above 1), the period of the food (liquid or gel) in the center of the tongue is sent to the pharynx

3) Pharyngeal phase

According to the above 2), the period of food (liquid or gel) that has been transported to the pharynx is transferred to the esophagus by swallowing reflex

4) Esophageal period

According to the above 3), the food (liquid or gel) is transported to the stomach by the peristaltic movement or gravity of the esophagus.

In addition to these periods, there is also a sentence in the period before the oral preparation period. "What kind of food" is eaten, and "the speed at which it is eaten" is the so-called "5-stage model" of the first phase.

Further, the step of "chewing and swallowing" is constituted by five steps (periods) of the following 1) to 5).

1) Predation and Stage I transport steps

Take the food into the mouth with the lips or front teeth (predation), and immediately move the whole tongue back, thereby moving the food placed on the tongue to the molars.

2) Food crushing steps

Following the above 1), the food reaches the molar portion, and the food is pulverized using the tongue, cheeks and caries, thereby forming a food mass.

At this time, the saliva and the food are thoroughly mixed, and in this step, the highest peak of the food pulverization is started simultaneously with the next Stage II transport step.

3) Stage II transport step

The food becomes chewed to become smaller, softer, and begins to become a condition suitable for swallowing (beginning to form a food mass).

At the same time, chewing and swallowing are carried out. When chewing, the pulverized food is also sent to the pharynx via the second stage of delivery, and the oropharynx (also including the oropharynx) accumulates to form a food mass.

4) Pharyngeal period

Next, in the above 3), the food piece that has been transported to the pharynx is transferred to the esophagus by swallowing reflection.

Observing the swallowing movement during the pharyngeal period of chewing and swallowing, and the linkage with the oral cavity, can be classified as: Consecutive pharyngeal swallow (CPS) accompanied by a series of tongue food transfer movements and separate occurrence without accompanying transfer It Isolated pharyngeal swallow (IPS (hereinafter, there are cases represented by IPS)) two types.

5) Esophageal period

According to the above 4), the food mass is transported to the stomach through the peristaltic movement or gravity of the esophagus.

In the chewing and swallowing, 4) the pharyngeal phase and 5) the esophageal phase are steps common to liquid swallowing.

When a food containing a liquid component and a solid component is swallowed, the liquid component contained in the food reaches the hypopharynx before the start of swallowing.

Because the pharyngeal isthmus is not closed during chewing, when the solid component is chewed in the oral cavity, the liquid component will flow downward due to the influence of gravity. During chewing, the pharyngeal head is opened, and the liquid component will swallow from the lower pharynx to the pharyngeal vestibule. Close.

Therefore, in the case of chewing and swallowing a food containing a liquid component and a solid component, since the liquid component is close to the opened pharyngeal head, the risk of the liquid component entering the trachea and being swallowed becomes high.

In elderly patients or stroke patients, foods containing liquid ingredients and solid ingredients are chewed and swallowed, and IPS occurs at a high frequency during the pharyngeal period. Therefore, it is considered that IPS is not able to properly perform chewing and swallowing exercise to protect the trachea from swallowing. In addition, in patients with stroke, the frequency of pharynx with IPS is high, and IPS can be said to be an important swallowing movement in the pharyngeal period.

In addition, the fluid is swallowed continuously while drinking liquid continuously, and when the liquid is swallowed in one bite, the dynamics are not the same. The dynamics of continuous swallowing are as shown in the following 1) to 3).

1) The throat is lowered after each swallowing, and the closing will swallow back to the original position, the throat Vestibular opening form

2) Although the throat is slightly lowered each time the swallowing is completed, it is in the form where the pharynx does not return to the original position, and the vestibule of larynx is not opened, and the form is swallowed directly next time.

3) Continuous swallowing in a state in which the swallowing of the above forms 1) and 2) is carried out

In the case of continuous swallowing, there is a report that the rate of intrusion into the throat is increased in the elderly, so it is an important swallowing exercise when judging the risk of swallowing such as an elderly person.

Thus, the chewing and swallowing of food consists of complex movement steps in which the tissues of the mouth, pharynx, and throat cooperate to operate, and various processes exist depending on the type or amount of food ingested and the state of the patient.

However, the examination medicines so far are mainly liquid, thick liquid or jelly, and although the function of "liquid swallowing" can be evaluated, it is impossible to evaluate a series of chewing and swallowing functions, and it is impossible to perform adequate and appropriate swallowing inspection.

In addition, the method for evaluating the swallowing function of a food mixed with liquid and solid is the same, and the liquid cockroach is mixed with corned beef for inspection as a food, but the salted beef has strong adhesion, so The dynamics of the separation of solids and liquids in the mouth are not meant to indicate the dynamics of chewing and swallowing in the usual diet. Therefore, in order to properly check the swallowing dynamics, it is necessary to provide a checker for better physical properties.

As mentioned, the previous inspection system can only check the dynamics or function of single swallowing when the liquid is swallowed, and even if it can be used for checking chewing and swallowing, it cannot be said to be an appropriate inspection object. In addition, there is no provision for examinations or examinations that can be used to check the degree of ingestion of swallowing movements/functions without specific criteria for the diagnosis of the degree of ingestion/swallowing.

The present invention provides a benchmark that can be used to specifically diagnose the extent of feeding/swallowing disorders, and It is a problem to check a series of inspection materials for ingestion and swallowing functions to solve these problems.

The present inventors have conducted intensive studies in view of the above-mentioned problems, and as a result, it has been found that a sample of a feeding, swallowing function of any one of a liquid, a viscous liquid, a jelly-like semi-solid or a viscous solid is present, or two or more types are mixed. The inspection material for ingesting the swallowing function formed by the inspection materials (hereinafter also referred to as the inspection material (mixture)) can be used as a reference for the specific diagnosis of the degree of ingestion/swallowing, and a series of ingestion swallowing functions can be examined.

Furthermore, it has been found that the inspection and swallowing function inspection materials can be judged and checked for the degree of movement, function or function of ingestion and swallowing, and can be more precise for humans with reduced feeding and swallowing function. The present invention has been completed by diagnosis or appropriate treatment.

By forming two or more of the inspection materials of the present invention, in particular, by mixing an inspection material exhibiting a swallowing function of any one of a liquid, a viscous liquid, a jelly-like semi-solid, and a viscous solid. The inspection material for ingesting swallowing function can more specifically judge and check the movement or function of the pharyngeal head when the food is swallowed, and the degree of the obstacle.

By providing such an examination material of the present invention, it is possible to determine the degree of detailed disorder of a subject such as a human ingesting a swallowing function, and to present an appropriate diet form accordingly. By this, it is possible to contribute to the prevention of aspiration, suffocation, and prevention of aspiration pneumonia in a diet such as a person who has reduced ingestion and swallowing function.

That is, the present invention relates to an inspection material or the like represented by the following (1) to (11).

(1) A test material for ingesting swallowing function, which is a liquid, viscous liquid, A test substance for ingesting swallowing function in any form of a jelly-like semi-solid or a viscous solid, or a test material for ingesting swallowing function formed by mixing two or more kinds of the test materials.

(2) The inspection material of the ingestion swallowing function according to the above (1), wherein the inspection material exhibiting a viscous solid form exhibits physical properties of any one of the following 1. to 3. The hardness is 10,000 N/ m ² to 100,000 N/m ² , 2. adhesion of 1,000 J/m ² to 5,000 J/m ³ , 3. aggregability of 0.2 to 0.6.

(3) A kit for ingesting swallowing function, which comprises an inspection material which exhibits the feeding and swallowing function of the viscous solid shape described in the above (1) or (2), and the following 1. to 4 Any one or more of the inspection materials; 1. The examination material for the feeding and swallowing function in liquid form; 2. The inspection material for the feeding and swallowing function in the form of a viscous liquid, 3. The feeding and swallowing function of the jelly-like semi-solid form Inspecting material, 4. Mixing inspection materials of two or more types of inspection materials of the following 1) to 4) for feeding and swallowing function.

1) A test material which exhibits a liquid form of ingestion and swallowing function, 2) a test material which exhibits a swallowing function in a viscous liquid form, 3) a test material which exhibits a swallowing semi-solid form of swallowing function, 4) exhibits the above (1) Or the inspection material of the feeding and swallowing function of the viscous solid form described in (2).

(4) The inspection material for feeding and swallowing function in a liquid form as described in the above (1) or (3), wherein the viscosity of the inspection material is measured at 20 ° C to 37 ° C at a shear rate of 10 sec ^-1 to 50 sec. ^{At -1} , the viscosity is 50mPa. s below.

(5) The inspection material for feeding and swallowing function in the form of a viscous liquid according to the above (1) or (3), wherein the viscosity of the inspection material is measured at 20 ° C to 37 ° C at a shear rate of 10 sec ^-1 to In 50sec ^-1 , the viscosity is 75 to 4,000mPa. s.

(6) The inspection material which exhibits the feeding and swallowing function of the jelly-like semi-solid form as described in the above (1) or (3), which is one or more of the following physical properties of 1. to 3. The hardness is 2,000 N/m ² to 10,000 N/m ² , 2. the adhesion is 400 J/m ³ or less, and the aggregability is 0.3 to 0.8.

(7) The test material which exhibits the feeding and swallowing function in the form of a viscous solid according to any one of the above (1) to (3), which is formed by containing a gel.

(8) The test material which exhibits the feeding and swallowing function in the form of a viscous solid according to any one of the above (1) to (3), which comprises the two gels described in the following 1. and 2. Former.

1. The pulverized gel which is directly solidified and then re-formed after the gel is first pulverized

2. Disperse the medium gel.

(9) A test material according to any one of the above (1) to (8), which comprises at least one of a contrast agent, a radioactive substance, a coloring agent or a luminescent agent.

(10) The inspecting material for ingesting swallowing function according to the above (9), wherein the contrast agent is a nonionic iodine-based contrast agent.

(11) The inspection material for ingesting swallowing function according to the above (9), wherein the coloring agent is a green pigment.

According to the present invention, by humans who have reduced feeding and swallowing function For more than one type of inspection material of the present invention, or a combination of the plurality of types, it is possible to inspect the extent of the ingestion swallowing movement or function, and to correctly judge and diagnose. In this way, humans who have reduced feeding and swallowing function can contribute to the prevention of aspiration, suffocation, and prevention of aspiration pneumonia.

The "inspecting material" of the present invention is a material for inspecting the swallowing function of a mammal such as a human, and is a material exhibiting any one of a liquid, a viscous liquid, a jelly-like semi-solid or a viscous solid.

The "inspection material" of the present invention may be an inspection material exhibiting a liquid form, an inspection material exhibiting a viscous liquid form, an inspection material exhibiting a jelly-like semi-solid form, or an inspection material exhibiting a viscous solid form, or may be a mixture. An inspection material formed by two or more such inspection materials.

Further, in the "inspection material" of the present invention, the inspection material of any one of a liquid, a viscous liquid, a jelly-like semi-solid or a viscous solid may be contained, and two or more types may be combined as they are. By.

In addition, in the physical properties of the "inspection material" of the present invention, "hardness", "adhesion" and "aggregation" described in the present specification are all based on "special use foods in accordance with the Japanese Ministry of Health, Labour and Welfare". The "hardness", "adhesion" and "aggregation" shown in the measurement are described in the test method described in the permission standard for foods for people with dysphagia.

Here, "hardness" means that each of the inspection materials of the present invention or a part thereof is used as The sample is filled in a container having a diameter of 40 mm so that the height is 15 mm (sample temperature: 20 ± 2 ° C), and the device can measure the compressive stress of the material by linear motion (for example, creep meter RE2-33005B: mountain The sample was made of a resinous plunger having a diameter of 20 mm and a height of 8 mm and compressed at a compression speed of 10 mm/sec into a maximum compressive stress at a clearance of 5 mm.

In addition, "adhesion" refers to the area occupied by the stress and time required to perform the same operation as the above-mentioned "hardness", which is required to reverse the compressive stress when the plunger is pulled from the sample after compression (adhesion energy) ) shown.

In addition, "aggregation" means performing the same operation as the above-mentioned "hardness", and compresses the sample twice, and indicates the second compression result with respect to the area in the graph showing the compressive stress and time of the first compression result. The ratio of the area of compressive stress to the area in time.

In the description of the physical properties of the "inspection material" of the present invention, the "shear stress" described in the specification refers to a measurement temperature of 20 ° C to 37 ° C and a shear rate of 10 sec ^-1 to 50 sec ^-1 . The "shear stress" expressed as a numerical value in the result of measuring the viscosity of the sample by a viscosity measuring instrument. As a viscosity meter which can measure such "shear stress", a cone-plate type rotary viscometer or the like can be exemplified.

Further, the viscosity measurement value of the inspection material in the form of "viscous liquid" is changed depending on the shear rate (number of rotations) at the time of usual viscosity measurement. An inspection material containing a tackifier used in general foods and exhibiting a "viscous liquid" form is a flow characteristic in which shear thinning occurs as the shear rate increases and the viscosity decreases. The setting of the shear rate is preferably carried out in accordance with conditions which cause a clinically reflected viscosity. Therefore, the present invention is based on an elderly person or a patient with mild dysphagia who is required to perform the examination of the present invention as a subject, and various viscous liquids to which a viscosity-increasing agent having different flow characteristics is added (usually used clinically) A thick liquid in the viscosity range was used as a sample to carry out a functional test for comparing the viscosity (degree of thickening). Then, the subject was investigated for a shear rate range in which the viscosity measurement values of the samples having the same viscosity (consistency) were consistent. As a result, it is set as the range of the viscosity measurement of the present invention which is set to "the range of the shear rate in which most of the subjects feel the viscosity is almost the same when swallowing".

In the inspection materials of the present invention, the inspection material exhibiting a "liquid" form needs to exhibit a water-like behavior, and the speed from the oral cavity to the pharyngeal head is fast. Thereby, it is possible to evaluate the movement and coordination of the movement from the oral cavity to the pharynx during swallowing.

The test material of the present invention which exhibits a "liquid" form preferably has a shear rate of 10 sec ^-1 to 50 sec ^-1 and represents 1 mPa when measured at 20 ° C to 37 ° C. Above s, 50mPa. s below the viscosity. Because the viscosity of drinking water is almost 1mPa. s, so its viscosity does not need to be lower, if it exceeds 50mPa. s, the water pharyngeal examination will become difficult. Also, because the viscosity exceeds 6mPa. In the case of s, the sensitivity of the detection of moisture is slow, so the present invention exhibits a "liquid" form of inspection material to indicate 1 mPa. s above 6mPa. The viscosity below s is particularly good.

When the present invention exhibits a "liquid" form of the inspection material, water is an essential component, and depending on the use of the inspection material, it may contain a contrast agent such as iohexol ( Iohexol ), a radioactive substance, a color developer, or the like, or may contain other substances. Additives.

As an inspection material which exhibits a "liquid" form, the present invention can be exemplified by adding a contrast agent, a radioactive substance, a coloring material or a color developing agent which can effectively perform the inspection of the ingestion and swallowing function in water, and further adding a phosphoric acid which enhances the preservation stability. It is composed of a preservative such as a pH adjuster such as a buffer or a preservative, or a seasoning such as a flavor/sweetener which is easy to drink. Moreover, as the inspection material of the "liquid" form of the present invention, In order to enhance the flavor, the emulsion may further contain an emulsion liquid obtained by emulsifying the emulsified material and having a good flavor.

Further, in the inspection materials of the present invention, the inspection material in the form of "viscous liquid" is present, and has a viscous and cohesive feeling, and the passage speed from the oral cavity to the pharynx is higher than that of the examination material in the form of "liquid". slow. Thereby, it is possible to evaluate the extent of the obstacle reflection and synergy of the subject from the oral cavity to the pharyngeal movement when swallowing, in the same manner as the examination material exhibiting the "liquid" form.

In the present invention, the inspection material of the form of "viscous liquid" is preferably measured at 20 ° C to 37 ° C, and the shear rate is 10 sec ^-1 to 50 sec ^-1 to indicate 75 mPa. s above 4,000mPa. s below the viscosity. If it is less than 75 mPa ‧ , it is low viscosity, and when it passes through the pharynx, the fluidity is a behavior similar to the inspection material in which the "liquid" form is present, and it becomes difficult to check whether or not the food is swallowed. In addition, if it exceeds 4,000mPa. s, because it is highly viscous, resulting in no fluidity, indicating a behavior similar to the inspection material in the form of "gelatinous semi-solid", and the result of inspection of liquid swallowing by viscous liquid inspection is not obtained.

Also, even the viscosity is 150mPa. s below, the sensitivity of the food to detect the liquid is still slow, at 600mPa. When the viscosity is above s, the correctness of the movement/dynamics of the swallowing of the liquid for dysphagia is lowered. Therefore, the particularly good shearing speed is 150 mPa in 50 sec ^-1 . s above 600mPa. s below the viscosity.

In the preparation of the inspection material of the present invention in the form of a "viscous liquid", water and an adhesion promoter are essential components, and depending on the use of the inspection material, a contrast agent such as iohexol, a radioactive substance, a color developer, or the like may be contained or Other additives. These tackifiers, contrast agents, radioactive materials, color developers, and the like are not particularly limited and may be replaced by other types.

That is, the tackifier required for preparing the test material of the present invention in the form of a "viscous liquid" can be used as long as it can prepare a "viscous liquid" form of the present invention having the above-described function. The type or amount of addition is particularly limited. Further, when one or more types of tackifiers are added, when two or more types of tackifiers are added, they may be added in any order during the preparation.

As the tackifier, xanthan gum, guar gum, pectin, locust bean gum , sodium carboxymethylcellulose (CMC-Na), alginic acid can be exemplified. Salt, etc., may also be heated as needed, and a dissolution aid may be added. In addition to the tackifier, a gelling agent may be added in an amount that does not form a gel.

Among the tackifiers, locust bean gum is prepared by using locust bean (Ceratonia siliqua) as a raw material. This person is also known as the carob bean, which is the seed of the leguminous plant known as Ceratonia siliqua. Therefore, locust bean gum can also be used in the present invention as long as it is a rubber which can be prepared from the raw materials, and is not particularly limited, and can be used as a raw material of the inspection material of the present invention.

Further, Sanxianjiao is a polysaccharide produced in vitro by Xanthomonas campestris, and is not particularly limited as long as it is equivalent to Sanxianjiao, and can be used as a raw material of the test agent of the present invention.

In addition, in the inspection material of the present invention, the inspection material in the form of a "gelatinous semi-solid" is required to flow without being caused by its own weight, and the shape does not collapse, and is low in adhesion and easy to deform, and is easily passed. Oropharyngeal. Thereby, it is possible to evaluate the extent of the obstacle reflection and synergy of the subject from the oral cavity to the pharynx when swallowing, in the same manner as the examination material in the form of a "viscous liquid". In addition, it is also possible to evaluate the function of sending to the pharynx and assessing the suitability of the pharyngeal reflex.

Such an inspection material of the present invention exhibiting a "gelatinous semi-solid" form, Preferably, it is one or more of the following physical properties of 1) to 3).

1) Those having a hardness of 2,000 N/m ² to 10,000 N/m ² . More preferably, the hardness is from 2,500 N/m ² to 6,000 N/m ² .

2) Adhesiveness is 400 J/m ³ or less.

3) Agglutination is 0.3 to 0.8.

In the above 1), the preferred hardness of the inspection material of the present invention exhibiting a "gelatinous semi-solid" morphology is 2,000 N/m ² to 10,000 N/m ² , which is less than 2,000 N/m. ² , because it is too soft, the tissue is easy to disintegrate in the oral cavity, and the function of the examination material in the form of "gelatinous semi-solid" is lost in the pharynx, and it is similar to the behavior of the examination material in the form of "viscous liquid". Therefore. In addition, if it exceeds 10,000 N/m ² , it is hard to be used as an examination material for evaluation of chewing and swallowing, and the degree of the obstacle of the subject becomes difficult. It is impossible to check by passing the pharynx.

In addition, when it is less than 2,500 N/m ² , it will easily disintegrate due to the oral dysfunction of the subject, and the function as an examination material which originally exhibits a "gelatinous semi-solid" form will be lost, and the precision of inspection will be made. The situation is getting lower. Moreover, when it exceeds 6,000 N/m<^2> , it will become difficult to pass the pharynx for the whole low-fat test which swallows the pharynx when it swallows, and the precision of the examination becomes low. Therefore, the hardness is preferably from 2,500 N/m ² to 6,000 N/m ² .

In the above 2), the test article of the present invention exhibits a preferred adhesion of the test material in the form of a "gelatinous semi-solid" of 400 J/m ³ or less, and if it exceeds 400 J/m ³ , the adhesion is high, and the entire process is performed. When swallowing, it causes significant residue in the pharynx, because the residue makes it difficult to observe the movement through the pharynx, and the precision of the examination result is deteriorated. Thus, presenting "jelly semi-solid" form of inspection of the adhesion member, does not remain in the system to the pharynx, it is easy to observe the dynamics of 400J / m ³ or less is preferred, 10J / m ³ to 100J / m ³ is more preferably .

In the above 3), the test article of the present invention exhibiting a "gelatinous semi-solid" morphology preferably has a cohesiveness of 0.3 to 0.8, which is brittle when the agglutinability is less than 0.3, and passes through the pharynx. It will slowly disintegrate, and its disintegration will remain in the pharynx, making it difficult to observe the movement of the pharynx, and the precision of the examination result will be deteriorated.

In addition, when the agglutinability exceeds 0.8, it is less likely to disintegrate due to deformation by external compression, or immediately return to the original physical property even if it is disintegrated. Therefore, when the pharyngeal head is closed, it is less likely to collapse due to pressure load. Solution, and there is a risk of occlusion / suffocation.

When preparing the inspection material of the present invention in the form of a "gelatinous semi-solid" form, water and a gelling agent or an adhesion promoter are essential components, and depending on the use of the inspection material, a contrast agent such as iohexol may be contained, and radioactivity may be contained. Substance, developer, etc. or other additives. These gelling agents, tackifiers, contrast agents, radioactive materials, color developing agents, and the like are also not particularly limited and may be replaced by other types.

That is, in preparing the test material of the present invention in the form of a "gelatinous semi-solid" form, the necessary tackifier or gelling agent can form a "gelatinous semi-solid" form of the present invention as long as it can prepare the above-mentioned function. The inspection material can be any one, and the type or addition amount thereof is not particularly limited. Further, when one or more types of tackifiers or gelling agents are added, when two or more types of tackifiers or gelling agents are added, they may be added in any order during preparation.

The tackifier or gelling agent can be exemplified by agar, carrageenan, gelatin, sansin, guar gum, pectin, locust bean gum, sodium carboxymethylcellulose, alginate Etc., heating may also be carried out as needed, and a dissolution aid may be added.

Among the tackifiers or gelling agents, the agar is prepared from red algae such as broccoli and asparagus, and is not particularly limited as long as it is equivalent to agar, and can be used as a raw material of the test material of the present invention.

Further, in the inspection material of the present invention, the inspection material in the form of "viscous solid" has a hardness to be chewed, and it is confirmed that the food piece is formed, and the food is fed to the pharynx in stages, and in addition, when coexisting with the liquid, it is required It was confirmed that the solid phase and the liquid phase were separated during chewing, and the mixture was swallowed by swallowing the liquid phase, followed by swallowing the solid phase. Thereby, it is possible to evaluate the degree of disorder of the movement and function of the chewing and swallowing as a model of the swallowing dynamic step.

In the present invention, the present invention exhibits a "viscous solid" form of the test material, and preferably exhibits any one of the following properties 1) to 3), and more preferably represents all of the physical properties.

1) A hardness of 10,000 N/m ² to 100,000 N/m ² . More preferably, the hardness is from 20,000 N/m ² to 50,000 N/m ² .

2) The adhesion is from 1,000 J/m ³ to 5,000 J/m ³ .

3) Agglutination is 0.2 to 0.6.

In the above 1), the hardness of the inspection material of the present invention exhibiting a "viscous solid" morphology is preferably from 10,000 N/m ² to 100,000 N/m ² because the hardness at the maximum compressive stress is less than 10,000 N. At /m ² , it may be difficult to evaluate the chewing function of the unchewed swallowing food, and when the hardness exceeds 100,000 N/m ² , it is difficult to evaluate the inability to chew the feeding function of the patient whose chewing power is lowered. Happening.

In addition, when the hardness was less than 20,000 N/m ² , it was not caused by chewing and swallowing without chewing. If it exceeded 50,000 N/m ² , the subject with reduced chewing ability would chew. Difficulty or chewing takes time to form an incomplete food mass, causing a pharyngeal head disorder, etc., and thus the inspection time becomes longer and the precision of the examination is impaired. Therefore, it is more preferred that the hardness is from 20,000 N/m ² to 50,000 N/m ² .

In the above 2), the test article of the present invention exhibits a preferred adhesion of the test material in the form of a "viscous solid" of 1,000 J/m ³ to 5,000 J/m ³ and an adhesion of less than 1,000 J/m ³ . The short residence time in the oral cavity leads to the fact that the food piece that has not been formed by chewing is transferred to the pharynx in the original state, so it is difficult to chew the diagnosis of swallowing function, and it is also difficult to diagnose the second stage of delivery in the chewing and swallowing (Stage II transport). In the step, the obstacle is diagnosed by the action of the food piece, or the possibility that the food piece remains in the pharynx is diagnosed. Moreover, when the adhesion of the test material exceeds 5,000 J/m ³ , the viscosity in the oral cavity is strong, and a large amount remains in the oral cavity, and a food mass having a coagulation feeling cannot be formed, and the speed of passing through the pharynx is slowed down. The inspection time becomes longer and the precision of the inspection is impaired.

The Stage II transport is mainly the movement that occurs when the solid is chewed and swallowed, and is the entire swallowing that is swallowed in a manner that will present a liquid or viscous liquid, a jelly-like semi-solid, etc. Movement that is not observed when the liquid is swallowed. Therefore, it is important to examine the motor function of the Stage II transport in assessing the degree of impairment of the feeding function of the solid to be chewed.

In the above 3), the test article exhibiting a "viscous solid" form of the present invention has a preferred aggregability of 0.2 to 0.6, and when the agglutination is less than 0.2, it becomes too dispersed in the oral cavity when chewed. It is difficult to form a food mass, and when the agglutination property exceeds 0.6, it is not easy to return to the original physical property by chewing or disintegrating, and it is not suitable for use in food pieces such as normal tongue movement for judging the feeding function at the time of chewing. Form a function.

In the preparation of such an inspection material in which the present invention exhibits a "viscous solid" form In the case of water, a gelling agent or a tackifier is an essential component, and depending on the use of the test material, a contrast agent such as iohexol, a radioactive substance, a color developer, or the like may be contained. These gelling agents, tackifiers, contrast agents, radioactive materials, color developing agents, and the like are also not particularly limited and may be replaced by other types.

That is, in the preparation of the "viscous solid" of the present invention, the tackifier or gelling agent used may be any one which can prepare a "viscous solid" form of the present invention having the above-described function. There is no particular limitation on the kind or amount to be added. Further, the tackifier or the gelling agent to be added may be one or more. When two or more kinds of tackifiers or gelling agents are added, they may be added in any order during the preparation.

In the present invention, the test material in the form of a "viscous solid" may be used as long as it is an examination material formed by containing a gel. For example, it can be prepared according to the following preparation method.

In the carboxymethyl cellulose sodium, locust bean gum, Sanxian gum, guar gum and other galactomannan-based tackifiers and / or water-soluble cellulose-based tackifiers, agar, reducing maltose and other dispersing agents Adding a contrast agent, a radioactive substance, a coloring agent or a luminescent agent to observe the dynamics of the material in the digestive tract, and adding a pH adjusting agent, a preservative, a preservative, a stabilizer, etc. as needed to form a gel. The preparation is an inspection material which exhibits a "viscous solid" form as the present invention.

Further, the inspection material of the present invention in the form of a "viscous solid" may be prepared according to the following preparation method.

Adding, contrast agent, radioactivity to galactomannan-based tackifiers such as sodium carboxymethyl cellulose, locust bean gum, and celestial gum, and/or water-soluble cellulose-based tackifiers and starch-insoluble polysaccharides a substance, a coloring agent, or a luminescent agent, etc., for observing the dynamics of the material in the digestive tract, and adding a pH adjusting agent, a preservative, a preservative, or the like as needed. A stabilizer or the like forms a gel to prepare an inspection material which exhibits a "viscous solid" form as the present invention.

In addition, the inspection material in the form of a "viscous solid" in the present invention may be an inspection material comprising a double gel structure which is dispersed by a "crushing gel" which is obtained by dispersing a gel. .

Here, the "pulverized gel" is a gel crusher formed by adding a tackifier, a gelling agent or the like to form a gel. The "crushed gel" is also contained in a contrast agent, a radioactive substance, a coloring agent or a luminescent agent, etc., for adding a substance such as a contrast agent, a radioactive substance, a coloring agent or a luminescent agent, for observing the dynamics of the material in the digestive tract, and It is necessary to add a pH adjuster, a preservative, a preservative, a stabilizer, etc. to form a gel, and the formed gel pulverizer or the like.

Moreover, the "dispersion medium gel" means a gel for dispersing the above-mentioned "pulverized gel", and is formed by adding a tackifier or a gelling agent. When the "crushing gel" or the like is mixed and stirred in the "dispersion medium gel", the "crushed gel" can be dispersed in a gel form, that is, the "dispersion medium gel" according to the present invention. "."

Such a test material having a double gel structure and exhibiting a "viscous solid" form can be prepared, for example, by a modulation method comprising the steps of 1) to 3) below.

1) Adding contrast agent and radioactivity to galactomannan-based tackifiers and/or water-soluble cellulose-based tackifiers and carboxymethylcellulose sodium other than locust bean gum, Sanxian gum, and locust bean gum A substance, a coloring agent, or a luminescent agent, etc., for observing the dynamics of the material in the digestive tract, and adding a pH adjusting agent, a preservative, a preservative, a stabilizer, etc. as needed to form a gel, which will form a gel. The rubber is pulverized to form a step of pulverizing the gel;

2) Adding agar and thorn as a dispersion medium gel to the pulverized gel of the above 1) A galactomannan-based viscosity-increasing agent other than locust bean gum, a contrast agent, a radioactive substance, a coloring agent or a luminescent agent, etc., for observing the dynamics of the material in the digestive tract, and mixing the pH adjusting agent as needed a preservative, a preservative, a stabilizer, or the like, followed by a step of stirring the dispersion gel to disperse the pulverized gel in the dispersion medium gel;

3) The above 2) is gelled again, and the two types of gels of the pulverized gel and the dispersion medium gel are used to form a double gel structure, and this is a step of exhibiting a "viscous solid" form of the inspection material of the present invention.

Further, as described above, the test material in the form of a "viscous solid" comprising the double gel structure of the present invention can be prepared, for example, by a modulation method comprising the steps of the following 1) to 5).

1) Adding an additive such as a contrast agent, a gelling agent and a tackifier to water, and heating and dissolving, cooling, and gelling step

2) Step of pulverizing the gel of the above 1)

3) Step of heating and dissolving the dispersion medium gel

4) a step of adding the dispersion medium gel of the above 3) to the pulverized gel of the above 2) and mixing

5) The step of sterilizing the gel exhibiting the double gel structure of the above 4), sterilizing it as needed, and cooling it to gel.

Further, when the test material having the double gel structure and exhibiting the "viscous solid" form of the present invention is prepared, the step of preparing the pulverized gel can be carried out in accordance with the following 1) and 2).

1) An additive such as a contrast agent, a gelling agent, and a tackifier are added to water, and the mixture is stirred and heated to dissolve. Further, since the gelling agent or the tackifier is not easily dissolved, it is preferably dispersed in a dispersing agent such as reduced maltose syrup at the time of addition, and is further added. Add to the water. Further, the dissolution needs to be heated to a temperature at which the gelling agent dissolves. In addition, the dispersing agent is not particularly limited as long as it does not form a spherical body which is hard to dissolve when the gelling agent or the thickening agent is dissolved, and is not particularly limited, and for example, lactose, white sugar or ethanol can be used.

After the gelling agent or the thickening agent is dissolved, if the stirring is stopped, it may be gelled by directly cooling to 40 ° C or lower, or may be transferred to another container for cooling to gel.

2) The step of pulverizing the gel prepared in the above 1). The pulverization system uses a propeller stirrer, a mixer, or the like, but the pulverized gel has a particle size of 2 to 3 mm or less, and the pulverizing machine or condition is not particularly limited. Further, it is preferred to pass the pulverized gel through a sieve or the like as needed to adjust the particle size.

Further, the dispersion medium gel dissolves the contrast agent and the gelling agent/tackifier in the same manner as the pulverized gel. Further, the pulverized gel prepared in the above manner was added and mixed at a temperature at which the dispersion medium gel did not gel (50 ° C or higher). After mixing, fill in a suitable container and heat sterilization as needed. Further, the conditions of heat sterilization are such that the gel does not dissolve. By adding a preservative or a preservative, it can be sterilized under mild heating conditions, cooled after sterilization, and gelled.

For the preparation of a "viscous solid" form of the test material formed by the double gel structure, the tackifier or gelling agent contained in the "crushed gel" is prepared as an inspection material exhibiting a "viscous solid" form. Preferably, it is possible to form a food mass having a chewing hardness of 20,000 N/m ² to 50,000 N/m ² in the oral cavity and a cohesiveness of 0.3 to 0.6 in the chewing. Examples of the tackifier or gelling agent include locust bean gum or sinica gum, and agar or carrageenan may be further added to the gums.

Further, in the case of such a tackifier or gelling agent, in order to prepare a test material which exhibits a "viscous solid" form as a double gel structure, it is expressed as "a diet which can be imparted to the subject when swallowed by the subject" The adhesion of 1,000 J/m ³ to 5,000 J/m ³ of the equivalent flow behavior of the food pieces is preferably the addition of a galactomannan-based tackifier other than locust bean gum and/or a water-soluble cellulose-based increase. Adhesive.

Among these tackifiers, the water-soluble cellulose-based tackifier can be exemplified by esterification of insoluble cellulose to form a water-soluble type of carboxymethylcellulose sodium (CMC.Na). .

Further, in the case of a galactomannan-based tackifier other than locust bean gum, guar gum prepared by Cyamopsis tetragonolobus or Tara gum prepared by Caselidinia spinosa can be exemplified. (tara gum). Among them, guar gum is preferably used, and it is not particularly limited as long as it is used as such a tackifier.

The present invention prepared in such a manner exhibits a "viscous solid" form of an inspection material, and an inspection material containing a double gel structure in the form of a "viscous solid", which is stored for 6 months even under a storage condition of 40 ° C. Nor did it see a significant change in the issue of physicality. Moreover, in the case of a conventional jelly, the physical properties change when stored under the same storage conditions for the same period of time. Therefore, the present invention exhibits an inspection material in the form of a "viscous solid" and an inspection material which exhibits a "viscous solid" form in a double gel structure, and can be an inspection material which is circulated in a state in which the physical properties are maintained for a long period of time.

In the present invention, an inspection material which exhibits a "liquid" form, an inspection material which exhibits a "viscous liquid" form, an inspection material which exhibits a "gelatinous semi-solid" form, or an inspection material which exhibits a "viscous solid" form are prepared. In addition, it is also possible to appropriately add: an auxiliary gelling agent or a viscosity-increasing agent, a sugar such as a reduced maltose syrup dissolved in water, or a pH adjustment of a preservative/preservative and a contrast agent from a microbiological point of view. A chelating agent, a flavoring sweetener or a flavoring agent, used as a raw material other than a tackifier or a gelling agent.

Further, various nutrients such as vitamins for restoring physical exertion at the time of swallowing angiography or various agents for suppressing inflammation during a swallowing may be added.

In the present invention, the test materials in any form of a liquid, a viscous liquid, a jelly-like semi-solid or a viscous solid can be combined to form a "inspection kit for ingesting swallowing function".

The "inspection kit for ingesting swallowing function" in the present invention refers to the purpose of checking the function of feeding and swallowing food, and the degree of normal functioning, etc., and it is necessary for the examination. The sample combination is used as a set.

The "inspection kit for ingesting swallowing function" of the present invention may be any one or more of "inspective materials of any one of liquid, viscous liquid, jelly-like semi-solid or even viscous solid in the present invention, or may be mixed. The inspection material formed by the two or more types of inspection materials may be used, and the inspection materials may be combined with other samples required for inspection. The "inspection kit for ingesting swallowing function" of the present invention is particularly preferable as an inspection material containing a form of a viscous solid.

In the inspection material of the present invention, in the "inspection kit", two or more types of inspection materials of the present invention may be further filled in the container to provide a test kit. When two or more kinds of inspection materials are combined, it is possible to use a container in which one container is partitioned by a partition wall, and each of the inspection materials can be separately filled.

The "inspection material of any one of liquid, viscous liquid, jelly-like semi-solid or even viscous solid" or "inspection material formed by mixing two or more such materials" and "containing one type" The result of the inspection of the inspection kits of the above-mentioned inspection materials may be appropriate for the subject of the food inspection material. Dietary form.

For example, in the inspection material of the present invention, it is possible to determine whether it is necessary to thicken the beverage to be ingested by the subject or the liquid for eating by the inspection result of the examination material in the form of "liquid".

Further, it is possible to judge whether or not the subject can ingest nutrients by the examination result of the examination material in the form of "viscous liquid".

Further, from the examination results of the examination material in the form of "gelatinous semi-solid", it is possible to judge whether or not the subject can ingest the jelly for direct training in the rehabilitation of the swallowing disorder.

Moreover, from the inspection result of the inspection material in the form of "viscous solid", it can be judged whether the subject can orally take in a soft material which is required to be chewed or crushed and which is not swallowed like liquid or jelly. "."

In addition, by examining the inspection result of the inspection material which is formed by mixing the inspection material in the form of "viscous solid" with the inspection material in the form of "liquid", it is possible to determine the taste of the soup containing the ingredients and the soup. Whether it is necessary to thicken the diet such as stewed food, whether it needs to be thickened for feeding.

Since the inventors of the present invention have the above-described functions of the "inspection materials" having the above-described forms, it is also possible to determine the degree of disorder of ingestion and swallowing by combining the respective "inspection materials" and sequentially inspecting them.

The following examples are shown in the following paragraphs 1. to 4. The specific examples of the degree of the ingestion of the swallowing of the subject by the examination of the inspected material of the present invention, or the combination, are not limited to the examples, but may be selected by Appropriate combination, and used for the inspection of swallowing function, the suggestion of diet, and the judgment of motor dysfunction in specific parts.

1. A combination of an inspection material exhibiting a viscous liquid form and an inspection material exhibiting a jelly-like semi-solid shape

If the above two types of examination materials are used for the ingestion swallowing examination, the risk of swallowing when ingesting food or the dysfunction of the basic feeding swallowing movement can be evaluated/determined as shown in the following 1) to 4).

1) In the examination of the examination materials, when the dysfunction of a swallowing or swallowing movement is observed in both of the examination materials, it can be judged that the food is difficult to eat and the swallowing dysfunction is extremely serious.

Moreover, from this result, a nutrient intake method such as enteral nutrition/tube irrigation or intravenous nutrition can be suggested.

2) In the examination of the inspection materials, dysphagia or swallowing movement dysfunction was observed in the examination material in the form of a viscous liquid, but when normal swallowing was observed in the examination material exhibiting a jelly-like semi-solid shape, It can be judged that although there is a risk of food swallowing and eating and swallowing disorders are serious, it still maintains a little function of chewing and swallowing.

Further, from the results, it is possible to suggest that even hardness/adhesion/aggregation is considered, for example, "a diet that is softened by gelatin or softened by an enzyme, and easily inhaled when left", or "even a small amount can be The diet form of the original swallowing is used as a method of ingesting nutrients.

3) In the inspection of the inspection materials, normal swallowing is observed in the inspection material in the form of a viscous liquid, and when the inspection material exhibiting a jelly-like semi-solid shape is observed to be dysfunctional or swallowing dysfunction, due to There are obstacles such as the food transfer movement, so it can be judged that the swallowing function is reduced due to the swallowing of the fluid by gravity, and the food is swallowed.

Further, from this result, it is suggested that a tackifier is added to the liquid to add a consistency to the diet form, for example, a thick-shaped/paste-like nutritious food having an additional consistency as a nutrient intake method.

4) In the inspection of the inspection materials, when the two inspection materials can be swallowed normally, it can be judged that there is no serious feeding and swallowing dysfunction caused by food aspiration.

Furthermore, it is possible to perform an examination by observing the movement state of the two examination materials in the oral cavity or by appropriately combining the examination materials which exhibit the liquid form, and to evaluate/determine the severity of the ingestion dysphagia in more detail. Or suggest a specific diet and so on.

2. A combination of a test material exhibiting a jelly-like semi-solid shape and an inspection material exhibiting a liquid form

Using the above two types of inspection materials for ingestion and swallowing, as shown in the following 1) to 4), the risk of water aspiration can be assessed/determined, or during food swallowing, especially the dynamic feeding function of the liquid swallowing form. .

1) In the examination of the examination materials, when the dysfunction of a swallowing or swallowing movement is observed in both of the examination materials, it can be judged that the dysfunction of the liquid swallowing is extremely serious.

Further, from this result, it can be judged that it is difficult to carry out all dietary forms (including moisture), and it is suggested that enteral nutrition/tube irrigation or intravenous nutrition is used as a nutrient intake method.

2) In the inspection of the inspection materials, although the inspection material exhibiting the jelly-like semi-solid form was not observed to be swallowed, the dysphagia or swallowing movement dysfunction was observed when the examination material in the liquid form was observed. It can be judged that the swallowing reflex of the pharyngeal period is abnormal, and there is a swallowing dysfunction of the liquid.

At this time, a further inspection was performed to observe the swallowing motion dynamics of the test material exhibiting a jelly-like semi-solid form. In this observation, although swallowed, in this movement When an abnormality is observed, it may be suggested to take into account a uniform hardness/adhesion/aggregation diet, such as "a diet that is softened by gelatin or softened with an enzyme, which is also easily inhaled when left in the mouth", or "Even if you have a small amount, you can swallow it as it is."

Further, when it is observed that the swallowing motion of the test material exhibiting a jelly-like semi-solid shape is normal, it can be judged that the hardness, the adhesion, and the agglutination property are considered as "the gelatin/pudding shape, or the enzyme can be softened by the enzyme". The diet, using a spoon to dig into a food block, the diet and so on.

3) On the other hand, the dysphagia or swallowing motor dysfunction is observed in the examination material exhibiting a jelly-like semi-solid shape, and the oral cavity in the liquid swallowing can be judged when the liquid-shaped examination material is not observed to be swallowed. There are obstacles to the preparation period or to the oral period.

Further, it can be judged that the eating form other than the liquid is difficult to ingest, and the oral nutrition by the liquid food is suggested.

4) For patients who have not swallowed both materials, they can be checked by observing the exercise state of the two materials in the oral cavity or using other forms of examination materials to determine the appropriate dietary form.

3. Combination of inspection material showing liquid form and inspection material exhibiting viscous solid form

Ingestion swallowing examination using the above two types of examination materials, as shown in the following 1) to 3), in the form of liquid swallowing, in addition to the chewing movement or the swallowing of the pharyngeal period In addition to the function, a more detailed evaluation/diagnosis can be made.

In this combination, the amount of the inspection material which exhibits the liquid form is changed while It is especially good to check the continuous swallowing function in the form of liquid swallowing while performing an examination.

1) In the inspection of this case, first check with a small amount (for example, about 5 mL) of the inspection material in the form of a liquid. As a result, when it is seen that there is a swallowing, in the liquid swallowing, there is a problem that the function of the swallowing reflex of the pharyngeal phase with high fluidity or the tissue movement of each period cannot function normally, and it can be evaluated as a water error. The danger of swallowing is high.

Therefore, when a small amount of the test material exhibiting a liquid form causes a swallowing, the chewing motion caused by the viscous solid and the movement to the pharyngeal head are observed. As a result, it is impossible to ingest and swallow when the chewing exercise is difficult, and it can be judged that it is difficult to ingest all the food by mouth.

Further, when it is observed during the examination that the chewing motion and the motion of the tissue associated with the tissue or the swallowing reflex system function slightly, (1) first, it is possible to suggest that uniform hardness/adhesion/aggregation is considered, for example, "for the gel A diet that softens the ingredients with enzymes and is easily inhaled when left in the mouth. Even a small amount can be swallowed in the form of a whole swallowed food; (2) Secondly, it can be suggested to make a thickened diet of (1) above. Form and so on.

In this examination, it is observed that when the chewing motion and the motion of the tissue or the swallowing reflex system function to some extent, it may be suggested that hardness/adhesion/aggregation is considered, for example, "the jelly/pudding may be formed. Or use a diet to soften the ingredients, use a spoon to dig into a food block, and the water has a thickened diet.

2) When the inspection of the inspection material having a small amount of liquid form in the above 1) is as follows, the inspection is carried out by a large amount (for example, 10 mL or more) of the inspection material in a liquid form.

In this examination, when swallowing or swallowing motor dysfunction is observed, in the liquid swallow In the pharyngeal form, although there is no problem in a single swallow, there is a problem in continuous swallowing for a high degree of motor function, and it can be judged that there is a problem in the tissue coordination system for continuous swallowing movement. Therefore, from this result, it can be suggested that the water supply is required to be thickened by adding a tackifier or the like.

3) In addition, in order to evaluate and determine the appropriate dietary form, an examination through a viscous solid is performed. As a result, it is possible to judge the detailed eating form while observing the degree of disorder of the oral chewing movement and the swallowing movement.

As a result of the examination, when a large amount (10 mL or more) of the test material in the form of a liquid was not swallowed, it was judged that there was no problem in the function of continuous swallowing in the liquid swallowing form.

In addition, in order to evaluate the judgment of a more appropriate diet, it is possible to judge whether or not to carry out the moisture while observing the results of the examination, the oral chewing movement, and the degree of disorder of the synergy with the swallowing movement when the examination is performed by the viscous solid. Add thickening, or judge the appropriate diet.

4. In the above-mentioned 3. The inspection material which exhibits the liquid form and the inspection material which exhibits the viscous solid form, a combination of the inspection materials in which the inspection materials (two types) are mixed is further added.

In addition, in the inspection material (2 types) of the above-mentioned 3., the inspection material which exhibits the liquid form and the inspection material which exhibits the form of the viscous solid are further added, and the food inspection is carried out, as shown in the following 1) to 4) It can be seen that in the form of chewing and swallowing to the extent of swallowing disorder, and a more detailed diet can be suggested.

1) When a small amount (5 mL) of the inspection material in the form of a liquid is not swallowed, a large amount (10 mL or more) of the inspection material in the form of a liquid and an inspection material exhibiting a liquid form are mixed with the inspection material exhibiting a viscous solid form. Inspection material (hereinafter referred to as inspection material) (mixture)) to check.

When both types of examination materials are confirmed to have abnormal function of swallowing movement such as swallowing or throat intrusion, it is possible to evaluate/determine that even if the basic liquid swallowing function is normal, there is a disorder of continuous swallowing, and the chewing movement in the mouth and the swallowing movement in the pharynx There are obstacles to coordination. Therefore, from this result, it is possible to suggest a food that does not need to be chewed, such as "mud/pasta/cursor/chopped food or a diet that softens the ingredients with an enzyme", and does not become sticky and easily condensed.

1) In addition, a large amount (10 mL) of the inspection material in the form of a liquid is observed to have abnormal function of a swallowing or swallowing movement, but when the examination material (mixture) is not confirmed to be swallowed, it can be evaluated/diagnosed although continuous in liquid swallowing. There are obstacles to swallowing movement, but solid food can be eaten during chewing and swallowing.

In this case, the chewing movement of the test material in the form of a viscous solid in the oral cavity can be further observed, and depending on the degree of the disorder, any of the following dietary forms (1) to (3) is suggested.

(1) When an obstacle is confirmed in the chewing movement, it is possible to provide a "food shape that is easy to form or transfer food pieces, which is difficult to disperse in the pharynx and easy to swallow, although it has a shape, but it can be crushed even without teeth." For example, a diet softened with an enzyme, etc.).

(2) When it is confirmed that the chewing exercise is mildly abnormal, the diet of the food and the conditioning method may be selected in consideration of the risk of aspiration and suffocation, and the diet which is not hard, is not easily dispersed, and is not easily attached to the oral cavity may be used. .

(3) When the chewing exercise is normal, it is a diet that prompts ordinary food and the like.

Further, in any of the cases (1) to (3), it is necessary to provide a water thickener.

3) On the other hand, although a large amount (10 mL) of the liquid material in the form of a liquid is invisible, the function of a swallowing or swallowing movement is observed by the inspection material (mixture). In case of abnormality, it can be evaluated/determined that although the dynamic or motor function of liquid swallowing is normal, the movement of the oral period during chewing and swallowing is synergistic with the swallowing of the pharynx or the swallowing reflex system.

In this form, the chewing movement of the examination material in the form of a viscous solid can be further observed, and depending on the degree of the disorder, any of the following dietary forms (1) to (3) is suggested.

(1) When chewing is difficult, it is suggested that even a small amount of hardness/adhesion/aggregation is considered, for example, "a diet that is softened by gelatin or softened by an enzyme, and easily inhaled when left in the mouth" The form of eating that can be swallowed as it is.

(2) Although it is confirmed that the chewing movement is abnormal, if there is no abnormality in the synergy between the swallowing movement after delivery to the pharyngeal head or the like, it is suggested that the mud/pasta/cursor/chopped food or the enzyme is softened by the enzyme. Diet, etc., will not be sticky, easy to condense the diet.

(3) When the chewing exercise is normal, it is suggested that although the shape of the food is maintained, it can be crushed even if there is no tooth, and it is easy to form or transfer the food block, and it is difficult to disperse in the pharynx, and it is easy to swallow the diet, for example, using enzyme softening. Diet and so on.

Further, in any of the cases (1) to (3), it is necessary to provide a thickener for moisture.

4) When the two types of inspection materials are not confirmed to be swallowed, it is possible to evaluate/determine that the water will not be swallowed in the form of liquid swallowing, and the water in the mixture of the solid component and the liquid component during chewing and swallowing may be swallowed.

In this case, the chewing movement of the examination material in the form of a viscous solid can be further observed, and depending on the degree of the disorder, any of the following dietary forms (1) to (4) is suggested.

(1) When it is difficult to chew, it is suggested that the muddy/paspy/cursor/chopped food, or the diet that softens the ingredients with enzymes, will not be sticky and easily condensed.

(2) Although it was confirmed that the chewing movement was abnormal, but the abnormality of the swallowing movement after being sent to the pharyngeal head or the like was not confirmed, it was suggested that although the shape of the food was maintained, it was crushed even without teeth, and it was easy to form. Or transfer food pieces, a diet that is difficult to disperse in the pharynx and easy to swallow, such as a softened diet using enzymes.

(3) Although it is confirmed that the chewing movement is mildly abnormal, when the abnormality of the swallowing movement after delivery to the pharyngeal head or the like is not confirmed, the diet is selected to take the food and the conditioning method in consideration of the risk of swallowing and suffocation. A diet that is hard, difficult to disperse, and difficult to attach to the mouth.

(4) When the chewing exercise is normal, it is a diet that prompts a normal diet.

As described above, by combining the inspection materials of the four forms or the inspection materials formed by mixing them, the function of ingesting and swallowing movement can be examined in detail, and an appropriate eating form or the like can be presented.

In addition, when all the four forms are combined, it is possible to present a detailed and appropriate eating form and the like from all eating forms for all patients who have swallowed dysphagia.

In addition, when an inspection material formed by mixing two or more kinds of "inspection materials for feeding and swallowing functions of any one of a liquid, a viscous liquid, a jelly-like semi-solid, or a viscous solid" as described above is used, Check the type or combination of materials and select them by visual inspection.

Further, the order in which the examination materials exemplified in the above 1 to 4 are used in the examination is only an example, and even if the order is changed, the degree of ingestion of the dysphagia can be checked or classified. The inspection materials used for the initial inspection can be used for inspection materials in the form of "viscous liquid", inspection materials in the form of "liquid", and inspection materials in the form of "gelatinous semi-solid". Classification of the degree of ingestion of swallowing disorders.

With such an "inspection material" of the present invention, the food is as described above. The classification of dysphagia can be used to treat patients with reduced swallowing function as never before. In addition, it is also possible to appropriately suggest a diet that takes into consideration the degree of disorder, and can contribute to prevention of aspiration, suffocation, and prevention of aspiration pneumonia in the diet.

In other words, according to the "inspection material" of the present invention, Mr. Kenji's "Diagnosis of the severity of dysphagia" can be classified (DSS classification) (Chito Ryoichi, feeding/swallowing disorder, latest rehabilitation medicine (Miben) Gongsan (supervised), 2nd edition, published by the Medical Tooth Company, 2005), the classification of severe cases was further classified into the sub-categories.

The inspection material in the form of "viscous solid" which is one of the "inspection materials" of the present invention can also be used to check the chewing function and the function of feeding to the pharynx when chewing and swallowing. An examination material exhibiting a "viscous solid" form can be used not only for swallowing, but also for example, in the case of eating and drinking, it is suspected that it is swallowed, and it is necessary to evaluate the problem of the condition of the pharynx and the condition of the chewing.

In addition, the present invention is referred to as an inspection material which exhibits a "liquid" form, or a liquid inspection material which exhibits a "viscous liquid" form, and an inspection material which is called a "gelatinous semi-solid" form, or In the inspection of the inspection material formed by mixing the solid inspection materials of the "viscous solid" form, the liquid separates and moves toward the pharynx during the chewing of the solid and the formation of the food pieces, although the visible solids are not accompanied. The systematic food block transfer movement, but a similar swallowing reflex (Isolated pharyngeal swallow (IPS)) can be used to diagnose the functional status of the IPS.

The inspection material of the present invention in the form of "liquid", the inspection material in the form of "viscous liquid", the inspection material in the form of "gelatinous semi-solid" or the inspection material in the form of "viscous solid" are required. A substance containing a contrast agent, a radioactive substance, a coloring agent, a luminescent agent, etc., which can observe the dynamics of the preparation in the digestive tract.

In order to make the present invention exhibit a "liquid" form of inspection material, an inspection material in the form of a "viscous liquid", an inspection material in the form of a "gelatinous semi-solid" or an inspection material in the form of a "viscous solid", each of which functions as a separate material. Therefore, these substances may be added in such a manner as to maintain stable physical properties, and may be added together with other components when preparing each test material, or may be added at the stage of preparing each test material.

The contrast agent, the radioactive substance, the coloring agent, the luminescent agent and the like can observe the dynamics of the preparation in the digestive tract, and can be selected according to the method of swallowing inspection.

For example, when swallowing imaging (VF) or Computed Tomography (CT) using an X-ray fluoroscopy apparatus is performed, it is preferable to add barium sulfate or an iodine-based contrast agent. At this time, since insoluble barium sulfate remains in the lungs for a long time when swallowed, and inflammation is induced, it is preferred to use an iodine-based contrast agent that rapidly disappears from the lungs.

Non-ionic people with low osmotic pressure in the iodine-based contrast agent have less influence on the lungs, and are more preferable. Further, in consideration of cost or taste, it is more preferable to use iohexol which is less expensive and has an unpleasant taste such as bitterness. In the inspection material of the present invention, the concentration of such contrast agent varies depending on the performance of the machine, and is usually from 3 w/v% to 80 w/v%, and in terms of VF inspection, preferably from 30 w/v% to 50 w. /v%, in terms of CT, is preferably from 3 to 10 w/v%.

Magnetic resonance imaging (MRI) can also be used for swallowing examination. At this time, the contrast agent is preferably added with manganese chloride tetrahydrate, hydrazine, ammonium ferric citrate or the like. Further, in the ultrasonic inspection method (Ultrasonography, US Echo), a microbubble suspension (sonazoid) containing a perfluorobutane (C ₄ F ₁₀ ) gas or the like may be added.

In the endoscopy (Video Endoscopy, VE), in order to distinguish between the examination material and the living tissue, it is preferable to add a pigment to the inspection material for coloring. Careful observation of its dynamics. In this case, if the color is colored in the green color as the complementary color of the color tone of the living tissue, the inspection material can be clearly observed, which is preferable.

In the present invention, the inspection material in the form of "liquid", the inspection material in the form of "viscous liquid", the inspection material in the form of "gelatinous semi-solid", and the inspection material in the form of "viscous solid" are all available. It is preferable to maintain an inspection material having high physical stability and stability for a long period of time.

For example, when preparing an inspection material of the present invention in the form of a "gelatinous semi-solid" form and an inspection material exhibiting a "viscous solid" form, if a non-ionic iodine-based contrast agent is added, especially in the neutral field, Iohexol can maintain the physical properties of the obtained test material for a long time and extremely stable. In particular, it has been found to have a remarkable effect on the stability of the jelly-like semi-solid and the physical properties of the viscous solid.

Moreover, it is preferable to add, for example, a pH adjuster, a chelating agent, a preservative, or a preservative to the test material which exhibits a "liquid" form, and to maintain a substance which is necessary for the examination of a contrast agent or the like, It is also preferred to heat-sterilize or sterilize the prepared inspection material as needed.

In addition, in the inspection material in the form of a "viscous liquid", in order to maintain physical properties such as viscosity for a long period of time, it is preferable to contain Sanxian gum as a tackifier and a nonionic iodine-based contrast agent as a contrast agent. Especially containing iohexol.

In addition to the three scented gums, in order to suppress the strong stringiness of the silk of the three sacred gums, and to leave the test material in the pharyngeal head, it is preferable to add the pulverizing property in the range which does not gelatinize. A galactomannan-based tackifier such as guar gum or glucomannan. The amount of the galactomannan-based tackifier or glucomannan added varies depending on the type of tackifier mixed with the three-scented gum. For example, when using guar gum, it is relative to Sanxian gum. The amount of guar gum added is preferably 10% by weight to 80%, especially in a way that is 10% to 30% mixed.

In addition, in order to maintain the physical properties such as hardness, adhesion, and agglutination, it is preferable to contain agar, locust bean gum, and a gum of a scented gum. Adhesives such as guar gum and carboxymethyl cellulose (CMC-Na). Further, it is preferable to use a nonionic iodine-based contrast agent as an additive, and particularly to use iohexol as an additive.

In the case of a general jelly food, as the storage time increases, the water is separated from the gel into a gel and the water layer is reduced in dehydration. However, the present invention in which the above-mentioned tackifier or the like is added is "frozen". The colloidal material of the form of colloidal semi-solids is less dehydrated during storage, and the addition of iohexol increases the long-term physical stability and hardly increases the dehydration.

In addition, in the inspection material which exhibits a "viscous solid" form, in order to show the same tendency as when chewing food, it is preferable to form "the smash can be easily pulverized by chewing, and the same adhesion as the food piece produced when chewing food can be maintained. The fine gel" is used as a pulverized material.

In order to obtain such a fine gel, it is preferred to directly disperse insoluble polysaccharides such as starch in an insoluble state in the gel structure. Thereby, at the time of chewing, it is easy to cause breakage of the gel at the adhesion boundary between the gel structure of the viscous solid and the insoluble polysaccharide, and it is easy to form a fine gel which is adhering to the pulverized material.

In addition, when the inspection material in the form of a "viscous solid" is an inspection material containing a double gel structure constructed of "pulverized gel" and "dispersion medium gel", the hardness, adhesion, and agglutinability of the stability are maintained for a long period of time. For the physical properties, it is preferred to use locust bean gum, Sanxian gum, water-soluble cellulose-based tackifier, galactomannan-based tackifier other than locust bean gum in the pulverized gel, and in the dispersion medium gel. Medium, preferably using agar, Cellulose tackifier, galactomannan tackifier.

Further, it is preferable to use a nonionic iodine-based contrast agent as an additive, and particularly iohexol as an additive, in the "inspection material exhibiting a viscous solid form".

The test material in the form of a "viscous solid" formed by the double gel structure containing the tackifier or the gelling agent is considered to be strong as a solid element and can be obtained according to the following reasons 1) to 3). Preservative stability.

1) In the pulverized gel, locust bean gum having a gel structure having a hard elasticity and adhesion is combined with Sanxian gum to form a gel which is durable against gravity or vibration.

2) In the dispersion medium gel, a galactomannan-based tackifier or a water-soluble cellulose compound other than locust bean gum which can be maintained by hydrogen bonding or the like together with the pulverized gel of the above 1) Tackifiers, especially combinations of guar gum or carboxymethylcellulose, inhibit the movement or movement of long-term water molecules within the gel structure.

3) By adding iodine-based contrast agent which is nonionic and has high affinity with water, in particular, iohexol is added, and it is strongly bonded to water molecules to lower the water activity.

It is preferable to add a nonionic iodine-based contrast agent, particularly iohexol, as a contrast medium for each of the examination materials for improving the long-term physical property preservation stability. The concentration of the contrast agent has a strong influence on the contrast ability at the time of examination. When the contrast agent added is iohexol, when the content in the test material is 20 w/v% or less, in the swallowing angiography examination, the dynamics of the diagnostic test material in the oral cavity, the pharyngeal head, and the esophagus cannot be adequately evaluated. Contrast ability. On the other hand, when it is 80 w/v% or more, in the swallowing angiography examination, although it has sufficient contrast ability in evaluation diagnosis, it is influenced by the taste such as the unique bitterness of the contrast agent, and it tends to be difficult to ingest. Moreover, at a high concentration of 80 w/v% or more, it is thickened or gelled, and each modulation is found. The physical properties are subject to change. Therefore, the results of these studies are as follows: the concentration of the contrast agent contained in the test material is preferably from 20 w/v% to 80 w/v%, and if the taste is changed or the stability of the physical property is taken into consideration, the concentration is preferably sufficient to have sufficient contrast. 30w/v% of capacity to 60w/v%.

Further, the test articles containing iohexol have a slightly bitter taste, and the bitterness may also affect the feeding and swallowing state. At this time, sweeteners or spices may be added as needed to mask bitterness. The type or addition amount of the sweetener or the flavor is not particularly limited, and any one may be used, but in order to mask the bitterness more effectively, if added: Thaumatin as a sweetener; as a spice and bitterness The flavor, such as a black sugar flavor, a chocolate flavor, a tea flavor or a black tea flavor, is preferred, and is preferably drinkable or ingested.

In the present invention, an "inspection material" which exhibits a "viscous solid" form and an examination material which exhibits a "liquid" form containing a nonionic iodine-based contrast agent having the above-mentioned concentration is mixed, in the swallowing imaging examination. The chewable substance formed by the examination material in the form of "viscous solid" in the oral cavity and the pharynx is separated from the liquid containing the nonionic iodine-based contrast agent of the above concentration, and the liquid and solid swallowed can be observed separately, so that it is daily In the diet, you can check whether there is any misdiagnosis caused by eating solid and liquid foods such as oolong noodles.

In the test materials of the present invention, the present invention exhibits a mixing ratio of the "viscous solid" form of the test material to the liquid containing the above-mentioned concentration of the nonionic iodine-based contrast agent, and the weight ratio is 8:2 to 2: The range of 8, preferably in the range of 7:3 to 5:5.

Further, in order to avoid the risk of dyspnea or suffocation, inhalation of foreign matter, inflammation, aspiration pneumonia or even death, the specimen of the present invention is required to be safely ingested in order to prevent the subject from swallowing the specimen during swallowing. Inspection material.

The present inventors have examined the form of a "gelatinous semi-solid" form and an examination material exhibiting a "viscous solid" form, and have been verified as a risk of tracheal occlusion in the case of a healthy normal person (a functional test). Any one of them does not feel the elasticity of suffocation, and it is easy to disintegrate through small deformation. Therefore, it can be confirmed that these inspection materials are easily disintegrated even when they are swallowed, and there is little risk of dyspnea or suffocation due to clotting of the trachea.

In addition, when the mouse was used as a subject to evaluate the effect on the lungs during a swallowing, it was found that the examination material in which the "liquid" form was added with iohexol was temporarily impaired in the lung after administration of the lung, but the extent was The water has the same degree of obstacles, and it is relatively fast. As long as it is the usual amount of pharyngeal, it will disappear from the lung within 6 hours to 8 hours after the aspiration. Therefore, it has been confirmed that the preparation of an iodine-based contrast agent, in particular, a non-ionic contrast agent such as iohexol having a low osmotic pressure can provide a test material which has a low influence on the lungs and is safer when swallowed.

The present invention exhibits a "liquid" form of an inspection material, an inspection material in the form of a "viscous liquid", an inspection material in a "gelatinous semi-solid" form, and an inspection material in a "viscous solid" form. It can be provided by directly filling the 5g to 20g in each container, tube, etc., by the means for inspection. Further, it may be provided by filling a container, a tube, or the like in an amount of 20 g or more. The shape of the container is not particularly limited.

In the case of the inspection of the inspection material of the present invention, the inspection material of the present invention is divided into a large mouth (5 g to 6 g) and administered to the subject in a spoon. For example, as long as it is an inspection material for VF inspection, the subject is ingested and swallowed by an X-ray contrast examination apparatus. Due to the invention administered to the subject Since the inspection material contains a sufficient amount of the contrast agent, it can be inspected without regard to the type of the X-ray contrast inspection apparatus.

In addition, as an example of a swallowing angiography test in which an examination material having a "viscous solid" form of the present invention and an examination material exhibiting a "liquid" form are mixed, the examination of the form of "viscous solid" is performed. In the case of the material 4g, the test subject is given 5 mL of the examination material in the form of "liquid". The inspection material exhibiting the "viscous solid" form and the examination of the "liquid" form can be appropriately changed depending on the state of the subject or the contents of the examination. The amount of wood and the mixing ratio.

After the test material is administered to the subject, the state of chewing and swallowing is performed by an X-ray contrast examination apparatus. Since the inspection materials contain a sufficient amount of the contrast agent, the inspection can be performed without considering the type of the X-ray contrast inspection apparatus.

Further, depending on the state of the subject, the type of the inspection material to be mixed can be selected, and it is not limited to the mixture of the inspection material in the form of "viscous solid" and the inspection material in the form of "liquid", and can be mixed from the inspection materials of the respective forms. A plurality of species are used in swallowing examinations.

Further, the concentration of the contrast agent contained in the test material of the present invention can be adjusted by differentiating the concentration of the contrast agent in other forms of mixing, and the test materials can be mixed to obtain a difference in contrast density. Each separates the dynamics of the examination materials of each form.

Hereinafter, the present invention will be described by way of examples and test examples, but the invention is not limited thereto.

(Example) [Test Example 1] Examination material in liquid form

The inspection material exhibiting a liquid form is prepared by the following steps from 1. to 3.

1. A pH adjuster (sodium dihydrogen phosphate dihydrate (manufactured by Wako Pure Chemical Industries, Ltd.) 42 mg and disodium hydrogen phosphate dodecahydrate (manufactured by Wako Pure Chemical Industries, Ltd.) 144 mg) was added to 66.9 g of water to adjust to pH 7. After 0, 32.8 g of iohexol (manufactured by Interphama Praha Co., Ltd.) was added and dissolved.

2. Next, add Sooma Sweet (made by Sanofong FFI Co., Ltd.) 0.4 mg, Yellow No. 4 (made by Sanyeon FFI Co., Ltd.), 9 mg, Blue No. 1 (manufactured by Sanyeon FFI Co., Ltd.), 3 mg, ethylenediamine Calcium acetate disodium (manufactured by Wako Pure Chemical Industries, Ltd.) 8.2 mg, paraben (manufactured by Ueno Pharmaceutical Co., Ltd.), and stirred while heating at 90 ° C, and added black tea flavor after cooling (Hayagawa Spice Co., Ltd.) Made) 33.4mg.

3. Water was added thereto to make the weight 100 g, and the mixture was uniformly stirred to prepare an inspection material in a liquid form.

The sample having a liquid form prepared by the above steps 1. to 3. has an iohexol content of 40 w/v%, and when the viscosity is measured at 20 ° C, the viscosity is 3.8 mPa at a shear rate of 10 sec ^-1 . s, at a shear rate of 50 sec ^-1 , the viscosity is 3.4 mPa. s. Moreover, the viscosity at a shear rate of 10 sec ^-1 was 2.3 mPa at 37 ° C. s, the viscosity is 2.3 mPa at a shear rate of 50 sec ^-1 . s. The test materials in a liquid form prepared by the above operations were filled in a plastic bottle so as to be 20 mL each.

[Test Example 2] Examination material showing a viscous liquid form

The inspection material exhibiting a viscous liquid form is prepared by the following steps 1. to 3.

1. A pH adjuster (sodium dihydrogen phosphate dihydrate (manufactured by Wako Pure Chemical Industries, Ltd.) 42 mg and disodium hydrogen phosphate dodecahydrate (manufactured by Wako Pure Chemical Industries, Ltd.) 144 mg) was added to 66.5 g of water to adjust to pH 7. After 0, 32.8 g of iohexol (manufactured by Interphama Praha Co., Ltd.) was added and dissolved.

2. Next, add Sooma Sweet (made by Sanofong FFI Co., Ltd.) 0.4 mg, Yellow No. 4 (made by Sanyeon FFI Co., Ltd.), 9 mg, Blue No. 1 (manufactured by Sanyeon FFI Co., Ltd.), 3 mg, ethylenediamine After adding 8.2 mg of calcium acetate disodium acetate (manufactured by Wako Pure Chemical Co., Ltd.) and p-hydroxybenzoic acid ester (manufactured by Ueno Pharmaceutical Co., Ltd.), it is added as a tackifier to Sanxianjiao (manufactured by DSP Wuxie Food & Chemical Co., Ltd.) 0.56g. 62.2 mg of guar gum (manufactured by Ina Food Industry Co., Ltd.) was stirred and dissolved while heating at 90 ° C, and after cooling, 33.4 mg of black tea flavored flavor (manufactured by Hasegawa Spice Co., Ltd.) was added.

3. Water was added thereto to make the weight 100 g, and the mixture was uniformly stirred to prepare an inspection material in the form of a viscous liquid.

The sample having a viscous liquid form prepared by the above steps 1. to 3. has an iohexol content of 40 w/v%, and when the viscosity is measured at 20 ° C, the viscosity is 1700 mPa at a shear rate of 10 sec ^-1 . s, at a shear rate of 50 sec ^-1 , the viscosity is 360 mPa. s. Moreover, when measured at 37 ° C, the viscosity was 674 mPa at a shear rate of 10 sec ^-1 . s, at a shear rate of 50 sec ^-1 , the viscosity is 198 mPa. s. The test material in the form of a viscous liquid prepared by the above operations was filled in a plastic bottle so as to be 20 mL each.

[Test Example 3] A test material exhibiting a jelly-like semi-solid form

The test material exhibiting a jelly-like semi-solid form was prepared through the following steps 1. to 3.

1. A pH adjuster (sodium dihydrogen phosphate dihydrate (manufactured by Wako Pure Chemical Industries, Ltd.) 42 mg and disodium hydrogen phosphate dodecahydrate (manufactured by Wako Pure Chemical Industries, Ltd.) 144 mg) was added to 66.8 g of water to adjust to pH 7. After 0, 32.8 g of iohexol (manufactured by Interphama Praha Co., Ltd.) was added and dissolved.

2. Next, add Sommer Sweet (made by Sanofong FFI Co., Ltd.) 0.4mg, Yellow No. 4 (three Manufactured by Rongyuan FFI Co., Ltd., 9 mg, Blue No. 1 (manufactured by Sanyin FFI Co., Ltd.), 3 mg, disodium edetate (manufactured by Wako Pure Chemical Industries, Ltd.), 8.2 mg, and p-hydroxybenzoate, As a gelling agent or tackifier agar (manufactured by Ina Food Industry Co., Ltd.) 0.14g, Sanxian Gum (made by DSP Wuxie Food & Chemical Co., Ltd.) 0.04g, locust bean gum (alias: locust bean gum, manufactured by MRC Polysaccharide Co., Ltd.) 0.02 g, 0.02 g of sodium carboxymethylcellulose (manufactured by Daiichi Kogyo Co., Ltd.), and 0.02 g of guar gum (manufactured by Ina Foods Co., Ltd.) were added to the reduced maltose syrup powder (manufactured by Mitsubishi Foods, Inc.) and added. The mixture was stirred and dissolved while heating at 90 °C.

3. The solution obtained in the above 2. was directly filled with 20 mL into a plastic-made jelly cup container without cooling, and then cooled, thereby preparing an inspection material which exhibited a jelly-like semi-solid form.

The test material having a jelly-like semi-solid form prepared by the above steps 1. to 3. has an iohexol content of 40 w/v%, a hardness of 3,200 N/m ² , and an adhesion of 60 J/m ³ , agglutinability. Is 0.4.

[Test Example 4] Examination materials showing the form of viscous solids (1) to (3)

75.45 g of iohexol (manufactured by Interphama praha Co., Ltd.) and 145.63 g of water were placed in a 500 mL stainless steel beaker, and stirred and dissolved. Next, add Sooma Sweet 0.8 mg, Yellow No. 4 (manufactured by Sanyeon FFI Co., Ltd.), 18 mg, Blue No. 1 (manufactured by Sanyeon FFI Co., Ltd.), 6 mg, and calcium diamine tetraacetate disodium hydrate (Wako Pure Chemical Co., Ltd.) The company produced 10 mg of trometamol as a pH adjuster and 121.1 mg of p-hydroxybenzoate (manufactured by Ueno Pharmaceutical Co., Ltd.). Then, 20.0 g of each of the gel raw material mixtures (three kinds) in which the gelling agent and the tackifier were mixed at the ratios shown in Table 1 were added thereto, and the mixture was suspended and dispersed while stirring. Dissolve this heat until it is cold after boiling At 60 ° C, 66.8 mg of black tea flavored flavor (manufactured by Hasegawa Spice) was added, and hot water was added to supplement the amount of water evaporated, and the total amount was adjusted to 240 g. Subsequently, the mixture was filled in a cup having a capacity of 25 g, sterilized at 85 ° C for 15 minutes, cooled, and allowed to stand at room temperature to be gelated. Thereby, three types of inspection materials (1) to (3) exhibiting a viscous solid form were obtained.

The physical properties of the test materials (1) to (3) in the form of a viscous solid prepared in the above manner were measured under the same conditions as in Test Example 1.

The materials (1) to (3) exhibiting a viscous solid form, the content of iohexol is 40 w/v%, as shown in Table 2, any of the materials exhibiting a viscous solid form, Hardness, adhesion, agglutination and the like all indicate better physical properties.

[Test Example 5] Examination materials showing the form of viscous solids (4) to (6)

In addition to the gelling agent and the tackifier, the total amount of the gel raw material mixture (3 types) mixed in the ratios shown in Table 3 was used, and the inspection materials (1) to (3) which exhibited the form of the viscous solid were used. In the same method of modulation, three kinds of inspection materials (4) to (6) exhibiting a viscous solid form were prepared. Thereafter, the physical properties of the test materials (4) to (6) which were prepared to exhibit a viscous solid form were measured under the same conditions as in Test Example 1.

The materials (4) to (6) exhibiting a viscous solid form, each of which has an iohexol content of 40 w/v%, as shown in Table 4, any of the materials exhibiting a viscous solid form, Hardness, adhesion, agglutination and the like all indicate better physical properties.

[Test Example 6] Examination material showing viscous solid form (7)

An inspection material containing a double gel structure exhibiting a viscous solid form was prepared by the following steps 1. to 3.

Preparation

The pulverized gel was prepared by the following steps 1) to 4).

1) A pH adjuster (sodium dihydrogen phosphate dihydrate (manufactured by Wako Pure Chemical Industries, Ltd.) 40 mg and disodium hydrogen phosphate dodecahydrate (manufactured by Wako Pure Chemical Industries, Ltd.) 137 mg) was added to 63.6 g of water to adjust to pH 7. After 0, 31.2 g of iohexol (manufactured by Interphama Praha Co., Ltd.) was added and dissolved.

2) Next, add Sooma Sweet (manufactured by Sanyin FFI Co., Ltd.) 0.4 mg, Yellow No. 4 (manufactured by Sanyeon FFI Co., Ltd.), 9 mg, Blue No. 1 (manufactured by Sanyeon FFI Co., Ltd.), 3 mg, Ethylenediamine After 7.8 mg of calcium acetate disodium acetate (manufactured by Wako Pure Chemical Industries, Ltd.) and an appropriate amount of p-hydroxybenzoic acid ester (manufactured by Ueno Pharmaceutical Co., Ltd.), the mixture was stirred and dissolved while heating at 90 ° C, and then black tea flavored flavor (manufactured by Hasegawa Spice) was added. Mg.

3) 2.5 g of scented gum (manufactured by DSP Wuxie Food & Chemical Co., Ltd.) and 2.5 g of locust bean gum (alias: locust bean gum, manufactured by MRC Polysaccharide Co., Ltd.), which are additionally added as a gelling agent or a tackifier. The mixture was heated to 80 ° C while stirring, and the weight was adjusted to 100 g with hot water. This was stirred uniformly and then cooled to cause gelation.

4) The gel formed by the above steps 1) to 3) is pulverized by a stirrer to prepare a pulverized gel.

2. Modulation of dispersion medium gel

The dispersion medium gel was prepared by the following steps 1) to 3).

1) Adding a pH adjuster (sodium dihydrogen phosphate dihydrate 42 mg and 67.2 g of water) After dissolving to pH 7.0, disodium hydrogen phosphate dodecahydrate 145 mg) was added and dissolved in 31.2 g of iohexol.

2) Next, add Sooma Sweet (manufactured by Sanyin FFI Co., Ltd.) 0.4 mg, Yellow No. 4 (manufactured by Sanyeon FFI Co., Ltd.), 9 mg, Blue No. 1 (manufactured by Sanyeon FFI Co., Ltd.), 3 mg, Ethylenediamine Calcium acetate disodium (manufactured by Wako Pure Chemical Industries, Ltd.) was added in an amount of 7.8 mg and p-hydroxybenzoic acid ester (manufactured by Ueno Pharmaceutical Co., Ltd.), and the mixture was stirred and dissolved while heating at 90 ° C, and then 33.4 mg of black tea flavor was added.

3) 1.0 g of guar gum (manufactured by Ina Foods Co., Ltd.), 0.25 g of sambag, and 0.15 g of agar (manufactured by Ina Foods Co., Ltd.) were added as a gelling agent or a tackifier, and heated to 90 while stirring. At °C, the weight was made 100g with hot water. Stir well and prepare a dispersion medium gel.

3. Modification of the shape of the viscous solid form

4 parts by weight of the above-mentioned prepared pulverized gel was mixed with 1 part by weight of the above-mentioned prepared dispersion medium gel in this ratio. The dispersing medium gel is heated and mixed in an ungelatinized state. The suspension prepared by stirring the mixture with a stirrer was directly filled with 20 g in a plastic gel cup container without cooling, and was cooled to serve as an inspection material in the form of a viscous solid.

The test material (7) having a viscous solid form prepared by the above steps 1. to 3. has an iohexol content of 40 w/v%, a hardness of 33,000 N/m ² , and an adhesion of 3,800 J/m ³ , The agglutinability is 0.5.

[Test Example 7] Examination material showing viscous solid form (8)

An inspection material containing a double gel structure exhibiting a viscous solid form was prepared by the following steps 1. to 3.

1. 40 g of iohexol (manufactured by Interphama Praha Co., Ltd.) and 52 g of water were placed in a 500 mL stainless steel beaker, and stirred and dissolved. Thereafter, 8.0 g of a pulverized gel raw material mixture in which a gelling agent or a tackifier was mixed in the ratio shown in Table 5, and a pH adjuster, a chelating agent, and the like shown in Test Example 1 in the same manner as in Test Example 1 were added. Preservatives, perfumes, sweeteners, and coloring materials are suspended and dispersed while stirring. After heating to boiling to dissolve, it was cooled to 60 ° C, and the evaporated water was replenished with water so that the total weight was 100 g. The mixture was uniformly mixed and then cooled to cause gelation. The gel formed by this operation was pulverized by a stirrer to obtain particles having a particle diameter of about 1 mm to prepare a pulverized gel.

2. The material containing the gelling agent or the tackifier shown in Table 6 and the same pH adjuster, chelating agent, preservative, perfume, sweetener, and coloring material as those of the dispersing agent of Test Example 6 were slowly added. Disperse while suspending it. Thereafter, the mixture was heated to boiling, and after cooling, it was cooled to 60 ° C, and the evaporated water was replenished with water to have a total weight of 124.3 g to prepare a dispersion medium gel.

3. 100 g of the pulverized gel prepared as described above was placed in a stirrer, and 31 g of the above-mentioned prepared dispersing medium gel was added thereto. The dispersing medium gel is added to the original state and is in an ungelatinized state. The pulverized gel and the dispersion medium gel were quickly mixed by a stirrer, filled in a cup having a capacity of 25 g, sterilized at 85 ° C for 15 minutes, cooled, and allowed to stand at room temperature to be gelated.

The test material (8) having a viscous solid form prepared by the above steps 1. to 3. has an iohexol content of 40 w/v%, a hardness of 21,000 N/m ² , and an adhesion of 1,800 J/m ^{3 .} The agglutination is 0.4. Either of them has the ideal physical properties as a viscous solid.

[Test Examples 8 to 12]

Except that the composition of the pulverized gel raw material mixture shown in Table 5 of Test Example 7 was changed to the composition shown in Test Examples 8 to 12 of Table 7, the test material showing the form of a viscous solid with the preparation of Test Example 7 (8) In the same manner, the comparative samples 1 to 5 were prepared. The physical properties of the prepared comparative sample were measured under the same conditions as in Test Example 1.

The results are shown in Table 8, and none of them exhibited the desired physical properties as an inspection material exhibiting a viscous solid form.

[Test Examples 13 to 15]

Except that the composition of the dispersion medium shown in Table 5 of Test Example 7 was changed to the composition shown in Test Examples 13 to 15 of Table 9, an examination material which exhibited a viscous solid form by the test Example 7 was used (8). The same method was used to prepare comparative samples 6 to 8. The physical properties of the prepared comparative sample were measured under the same conditions as in Test Example 1.

The results are shown in Table 10, and none of them exhibited the desired physical properties as an inspection material exhibiting a viscous solid form.

[Test Example 16] VF inspection (1)

In place of the iohexol contained in the above Test Example 7, except for the commercial use of iohexol, Omnipaque (registered trademark) 350 (containing iohexol 75.49 w/v%), and the content of iohexol was used. In addition to the amount of water added in a manner of 40 w/v%, a VF inspection of a healthy person is performed in a medical institution by a test material (8) which is prepared in the same manner as in Test Example 7 and is evaluated. The dynamics of chewing and swallowing were observed.

The VF device uses a digital X-ray TV system and a digital video recorder. The VF examination is to give the test substance 5g which is in the form of a sticky solid to the mouth of the subject, and instruct the subject to "make the taste by taste" and observe the VF inspection device. Inspect the free time of swallowing after free food intake.

As a result, after the examination material (8) exhibiting a viscous solid form was applied, a food mass was formed via a chewing motion, and then the Stage II transport of the food mass in the upper pharynx was observed while chewing. Next, it was observed that the food pieces accumulated in the pharynx were swallowed.

Therefore, it can be confirmed from the results that the examination material of the present invention exhibiting a viscous solid form can be sufficiently imaged for use in the VF examination.

[Test Example 17] VF inspection (2)

As an inspection material, it was prepared to replace the iohexol of Test Example 7 with the commercial product Omnifaque (registered trademark) 350 containing iohexol (containing 75.49 w/v% of iohexol), and In the same manner as in Test Example 7, the test material (8) 4g" which exhibits a viscous solid form in the same manner as in Test Example 7 and "Use of a city containing iohexol", and the amount of water to be added, were adjusted to 40 w/v%. The product, Olympus (registered trademark) 350 (containing iohexol 75.49 w/v%), was substituted for the iohexol in Test Example 1, and the amount of water addition was adjusted so that the iohexol content was 40 w/v%. An inspection material formed by mixing and mixing 5 mL of a test material in a liquid form prepared in the same manner as in Test Example 1.

This test piece was subjected to a VF test on a healthy person using the same apparatus as in Test Example 15, and it was investigated whether the dynamics of chewing and swallowing of the test material exhibiting the liquid form and the test material exhibiting the form of the viscous solid were observed. The VF examination was performed by injecting 4 g of the examination material in the form of a viscous solid with a spoon to the oral cavity of the subject, and then immediately injecting 5 mL of the examination material in a liquid form into the oral vestibule with a syringe, and then instructing the subject to "please The taste is tasted and chewed, and the VF inspection device is used to observe the free timing of swallowing after free feeding.

As a result, it was observed that after the test material (8) containing the form of the viscous solid contained in the test material was injected in the test, the food piece was formed by the chewing movement, during which the liquid was separated from the viscous solid, and only Liquid swallowing. Again, Stage II transport was observed in the upper pharyngeal mass, and then the food mass accumulated in the pharyngeal cap was observed to be swallowed.

Therefore, according to the result, each of the test materials mixed in the test material in which the test material of the present invention in a liquid form and the test material in a form of a viscous solid is mixed is sufficiently imaged. Again, these examination materials represent typical pharyngeal swallowing dynamics.

(industrial availability)

By the present invention, one or more inspection materials of various forms of liquid, viscous liquid, jelly-like semi-solid, and viscous solid, or a plurality of such inspection materials can be used to examine in detail that humans with reduced feeding function are equal to food intake. Or chewing or swallowing exercise or function, degree of disorder.

By adding a contrast agent, a radioactive substance, a coloring agent, a luminescent agent, etc. to the examination materials, X-ray fluoroscopy or endoscope, MRI, etc. are used to observe the dynamics of chewing and swallowing in the digestive tract, and the chewing and swallowing can be easily checked. The degree of exercise or function, obstacles.

Therefore, based on the results of the examination, it is possible to perform a precise diagnosis or appropriate treatment for a human being with a reduced feeding function, and to prevent a swallowing or suffocation in the diet by appropriately selecting a eating form that takes into consideration the degree of the disorder. Prevention of aspiration pneumonia and other contributions.

Claims (11)

An inspection material for ingesting swallowing function, which is an inspection material for feeding or swallowing function in any form of liquid, viscous liquid, jelly-like semi-solid or even viscous solid, or a mixture formed by mixing two or more kinds of the inspection materials Checking material for swallowing function. The inspection material of the ingestion swallowing function according to the first aspect of the invention, wherein the inspection material exhibiting a viscous solid form is a physical property showing any one of the following 1. to 3. The hardness is 10,000 N. /m ² to 100,000 N/m ² , 2. Adhesiveness of 1,000 J/m ² to 5,000 J/m ³ , 3. Aggregation of 0.2 to 0.6. The invention relates to a kit for ingesting swallowing function, which comprises the inspection material for feeding and swallowing function of the viscous solid form described in the first or second aspect of the patent application, and any one or more of the following 1. to 4. 1. Inspection material; 1. Inspecting material for feeding and swallowing function in liquid form; 2. Examination material for feeding and swallowing function in the form of viscous liquid, 3. Examination material for feeding and swallowing function in the form of jelly-like semi-solid, 4. Mixing Two or more inspection materials for the ingestion and swallowing function formed by the inspection materials of the following 1) to 4): 1) an inspection material exhibiting a liquid form of ingestion and swallowing function, and 2) an examination material for ingesting swallowing function in a viscous liquid form, 3) A test material which exhibits a swallowing semi-solid form of ingestion and swallowing function, and 4) an inspection material which exhibits the feeding and swallowing function of the viscous solid form described in the first or second aspect of the patent application. The inspecting material for ingesting swallowing function in liquid form as described in claim 1 or 3, wherein the viscosity of the test material is measured at 20 ° C to 37 ° C at a shear rate of 10 sec ^-1 to 50 sec ^{- In 1} , the viscosity is 50mPa. s below. The inspection material for feeding and swallowing function in the form of a viscous liquid according to the first or third aspect of the patent application, wherein the viscosity of the inspection material is measured at 20 ° C to 37 ° C at a shear rate of 10 sec ^-1 to 50 sec. ^{In -1} , the viscosity is 75 to 4,000 mPa. s. The inspection material which exhibits the feeding and swallowing function of the jelly-like semi-solid form according to the first or third aspect of the patent application, wherein the inspection material exhibits any one or more of the following physical properties: 1. to 3. Those having a hardness of 2,000 N/m ² to 10,000 N/m ² , 2. having an adhesion of 400 J/m ³ or less, and 3. having a cohesiveness of 0.3 to 0.8. The test material which exhibits the feeding and swallowing function in the form of a viscous solid according to any one of the first to third aspects of the invention, which comprises a gel. The inspection material exhibiting the feeding and swallowing function of the viscous solid form according to any one of the first to third aspects of the invention, which comprises the following two types of gels: 1. and 2. 1. The gel is first pulverized and then directly solidified to form a pulverized gel. 2. Dispersion medium gel. An examination material for ingesting a swallowing function, which is the inspection material according to any one of the items 1 to 8, which contains at least one of a contrast agent, a radioactive substance, a coloring agent or a luminescent agent. The inspecting material for ingesting swallowing function according to claim 9, wherein the contrast agent is a nonionic iodine-based contrast agent. The inspection material for ingesting swallowing function according to claim 9, wherein the coloring agent is a green pigment.